It is generally known in the art to use prosthetic devices to replace portions of the human anatomy that have been damaged due to injury or age. Often these prosthetic devices are formed of materials that are inherently strong yet easily formable. Many modular prosthetic devices are formed of at least metal stem portions that are inserted into long bones to provide a base for an external portion that extends from the boney portion. A taper or neck often interconnects the portion that extends from the bone, such as a head of a humerus or a femur, and the stem that is inserted in the bone. A taper may also be used to interconnect modular positions that are disposed within the bone after implantation. It is also known to provide bearing surfaces that must interact with one another while not wearing quickly or producing much wear debris.
The taper or neck that interconnects the two portions of the prosthesis, sometimes referred to as a Morse taper, must be strong enough to withstand cyclic loads that will be seen in a wide variety of anatomies, patient activity levels, and compromised boney constructs. The neck must also allow a range of movement that closely simulates the natural human anatomy. Other types of prosthetic devices are also modular and are formed from multiple interconnecting components. These components may also be interconnected by way of a Morse taper.
While materials generally used in these devices are inherently strong and have high tensile strengths, they require a particular thickness or mass to provide enough support for the portion of the anatomy that is being replaced. Due to this, the Morse taper is often larger and does not provide a full or natural range of motion. If the taper is for internal bone connection, a strong enough connection may produce a taper that is too big to fit into smaller bones. Due to this, it is desirable to produce prosthetic devices that include neck or interconnection portions that are small enough to fit into smaller bones and allow a full range of motion while being strong enough to support the stresses which the prosthetic will encounter.
One solution has been to provide new metal alloys that are particularly strong. These metal alloys may be formed into a myriad of shapes while still providing much of the support necessary for the prosthetic device. These new metal alloys, however, are still required to have large enough interconnection portions to provide the necessary strength to the materials.
Other known methods include the cold working or work hardening of prosthetics, such as that disclosed in the commonly assigned U.S. Pat. No. 6,067,701 entitled “Method for Forming a Work Hardened Modular Component Connector”, which is hereby incorporated by preference. These methods, however, include a certain amount of uncertainty introduced into the prosthetic device. Therefore, excessive or unnecessary work hardening may be performed or the prosthetic may not be work hardened enough, requiring an earlier replacement than necessary. In addition, other precautions, such as larger prosthetics, may unnecessarily be used to ensure proper strength.
Cold working induces residual stresses within the component and may also produce the required or different residual stresses within the component. Particular residual stresses can be either compressive or tensile depending upon their nature. Compressive residual stresses are particularly desired. In particular, compressive residual stresses inhibit or stop cracks which may form in the prosthetic device. Furthermore, compressive stresses inhibit the initiation of a crack within the area which is loaded by external forces.
Compressive stress, especially near the surface of the component, also provides additional benefits. In particular compressive stress near the surface can decrease fatigue and stress corrosion failures. In particular, these fatigue and stress corrosion failures originate at the surface and the compressive stress help inhibit such failures. In addition, the compressive residual stresses increase resistance to other undesired events such as fatigue failures, corrosion failure, stress corrosion cracking, hydrogen assisted cracking, fretting, galling, and corrosion caused by cavitation. Additionally, work hardening, which produces the compressive stresses, increases intergranular corrosion resistance, surface texturing, and closing of surface porosity.
Although compressive stresses, or other particular residual stresses, provide these many benefits, it is more beneficial to precisely create the desired residual stresses within the prosthetic device. Although exploratory cold working a component may produce the desired residual stresses, predetermining and work hardening components to produce predetermined residual stresses is preferable. Therefore, it is desired to provide a known process to produce within the prosthetic device, known and predetermined residual stresses that will provide compressive and tensile stresses, that are desired in a component.
Thus, it is desirable to have a method of producing prosthetic devices that leaves no uncertainty to the strength being introduced into the prosthetic device. This would allow for more efficient manufacturing and an increase in prosthetic strength that survive the testing phase. That is, it is desirable to produce a prosthetic device that needs not to be tested as often while still assuring that the prosthetic device will be able to handle the loads after being implanted.